Matthew S. Penn

A Transdisciplinary Approach to Public Health Law: The Emerging Practice of Legal Epidemiology

Public health law has roots in both law and science. For more than a century, lawyers have helped develop and implement health laws; over the past 50 years, scientific evaluation of the health effects of laws and legal practices has achieved high levels of rigor and influence. We describe an emerging model of public health law that unites these two traditions. This transdisciplinary model adds scientific practices to the lawyerly functions of normative and doctrinal research, counseling, and representation. These practices include policy surveillance and empirical public health law research on the efficacy of legal interventions and the impact of laws and legal practices on health and health system operation. A transdisciplinary model of public health law, melding its legal and scientific facets, can help break down enduring cultural, disciplinary, and resource barriers that have prevented the full recognition and optimal role of law in public health.

Policy Surveillance: A Vital Public Health Practice Comes of Age

Governments use statutes, regulations, and policies, often in innovative ways, to promote health and safety. Organizations outside government, from private schools to major corporations, create rules on matters as diverse as tobacco use and paid sick leave. Very little of this activity is systematically tracked. Even as the rest of the health system is working to build, share, and use a wide range of health and social data, legal information largely remains trapped in text files and pdfs, excluded from the universe of usable data. This article makes the case for the practice of policy surveillance to help end the anomalous treatment of law in public health research and practice. Policy surveillance is the systematic, scientific collection and analysis of laws of public health significance. It meets several important needs. Scientific collection and coding of important laws and policies creates data suitable for use in rigorous evaluation studies. Policy surveillance addresses the chronic lack of readily accessible, nonpartisan information about status and trends in health legislation and policy. It provides the opportunity to build policy capacity in the public health workforce. We trace its emergence over the past fifty years, show its value, and identify major challenges ahead.

Impact of laws aimed at healthcare-associated infection reduction: a qualitative study

Background Healthcare-associated infections (HAIs) are preventable. Globally, laws aimed at reducing HAIs have been implemented. In the USA, these laws are at the federal and state levels. It is not known whether the state interventions are more effective than the federal incentives alone. Objective The aims of this study were to explore the impact federal and state HAI laws have on state departments of health and hospital stakeholders in the USA and to explore similarities and differences in perceptions across states. Methods A qualitative study was conducted. In 2012, we conducted semistructured interviews with key stakeholders from states with and without state-level laws to gain multiple perspectives. Interviews were transcribed and open coding was conducted. Data were analysed using content analysis and collected until theoretical saturation was achieved. Results Ninety interviews were conducted with stakeholders from 12 states (6 states with laws and 6 states without laws). We found an increase in state-level collaboration. The publicly reported data helped hospitals benchmark and focus leaders on HAI prevention. There were concerns about the publicly reported data (eg, lack of validation and timeliness). Resource needs were also identified. No major differences were expressed by interviewees from states with and without laws. Conclusions While we could not tease out the impact of specific interventions, increased collaboration between departments of health and their partners is occurring. Harmonisation of HAI definitions and reporting between state and federal laws would minimise reporting burden. Continued monitoring of the progress of HAI prevention is needed.

Resource-Poor Settings: Infrastructure and Capacity Building: Care of the Critically Ill and Injured During Pandemics and Disasters: CHEST Consensus Statement

BACKGROUND Planning for mass critical care (MCC) in resource-poor or constrained settings has been largely ignored, despite their large populations that are prone to suffer disproportionately from natural disasters. Addressing MCC in these settings has the potential to help vast numbers of people and also to inform planning for better-resourced areas. METHODS The Resource-Poor Settings panel developed five key question domains; defining the term resource poor and using the traditional phases of disaster (mitigation/preparedness/response/recovery), literature searches were conducted to identify evidence on which to answer the key questions in these areas. Given a lack of data upon which to develop evidence-based recommendations, expert-opinion suggestions were developed, and consensus was achieved using a modified Delphi process. RESULTS The five key questions were then separated as follows: definition, infrastructure and capacity building, resources, response, and reconstitution/recovery of host nation critical care capabilities and research. Addressing these questions led the panel to offer 33 suggestions. Because of the large number of suggestions, the results have been separated into two sections: part 1, Infrastructure/Capacity in this article, and part 2, Response/Recovery/Research in the accompanying article. CONCLUSIONS Lack of, or presence of, rudimentary ICU resources and limited capacity to enhance services further challenge resource-poor and constrained settings. Hence, capacity building entails preventative strategies and strengthening of primary health services. Assistance from other countries and organizations is needed to mount a surge response. Moreover, planning should include when to disengage and how the host nation can provide capacity beyond the mass casualty care event.

Legal considerations in cross-jurisdictional sharing of public health laboratory services.

The Centers for Disease Control and Prevention and the Association of Public Health Laboratories initiated the Laboratory Efficiencies Initiative in 2011 to help address issues related to public health laboratory (PHL) capacity to perform critically needed tests and services. One approach to improving capacity and efficiency is sharing PHL services with other states or jurisdictions. Cross-jurisdictional sharing implicates numerous federal and state laws, including federal and state privacy laws, laboratory certifications, packaging and shipping requirements for laboratory specimens, and state laws regarding fees and revenue. While federal laws generally do not present insurmountable barriers to sharing PHL services, state laws vary greatly, even within the same region of the country. This article summarizes some of the potentially relevant federal and state legal issues related to cross-jurisdictional sharing. It is important that states interested in cross-jurisdictional sharing consider all relevant laws, potential conflicts of law, as well as inconsistencies with agreements already in place among health departments and laboratories.

Legal preparedness: care of the critically ill and injured during pandemics and disasters: CHEST consensus statement.

BACKGROUND Significant legal challenges arise when health-care resources become scarce and population-based approaches to care are implemented during severe disasters and pandemics. Recent emergencies highlight the serious legal, economic, and health impacts that can be associated with responding in austere conditions and the critical importance of comprehensive, collaborative health response system planning. This article discusses legal suggestions developed by the American College of Chest Physicians (CHEST) Task Force for Mass Critical Care to support planning and response efforts for mass casualty incidents involving critically ill or injured patients. The suggestions in this chapter are important for all of those involved in a pandemic or disaster with multiple critically ill or injured patients, including front-line clinicians, hospital administrators, and public health or government officials. METHODS Following the CHEST Guidelines Oversight Committees methodology, the Legal Panel developed 35 key questions for which specific literature searches were then conducted. The literature in this field is not suitable to provide support for evidence-based recommendations. Therefore, the panel developed expert opinion-based suggestions using a modified Delphi process resulting in seven final suggestions. RESULTS Acceptance is widespread for the health-care communitys duty to appropriately plan for and respond to severe disasters and pandemics. Hospitals, public health entities, and clinicians have an obligation to develop comprehensive, vetted plans for mass casualty incidents involving critically ill or injured patients. Such plans should address processes for evacuation and limited appeals and reviews of care decisions. To legitimize responses, deter independent actions, and trigger liability protections, mass critical care (MCC) plans should be formally activated when facilities and practitioners shift to providing MCC. Adherence to official MCC plans should contribute to protecting hospitals and practitioners who act in good faith from liability. Finally, to address anticipated staffing shortages during severe and prolonged disasters and pandemics, governments should develop approaches to formally expand the availability of qualified health-care workers, such as through using official foreign medical teams. CONCLUSIONS As a fundamental element of health-care and public health emergency planning and preparedness, the law underlies critical aspects of disaster and pandemic responses. Effective responses require comprehensive advance planning efforts that include assessments of complex legal issues and authorities. Recent disasters have shown that although law is a critical response tool, it can also be used to hold health-care stakeholders who fail to appropriately plan for or respond to disasters and pandemics accountable for resulting patient or staff harm. Claims of liability from harms allegedly suffered during disasters and pandemics cannot be avoided altogether. However, appropriate planning and legal protections can help facilitate sound, consistent decision-making and support response participation among health-care entities and practitioners.

Transitioning from Paper to Digital: State Statutory and Regulatory Frameworks to Address Health Information Technology

Objectives: In all health system sectors, electronic health information (EHI) is created, used, released, and reused. We examined states’ efforts to address EHI uses in law to provide an understanding of the EHI legal environment. Methods: Attorney researchers used WestlawNext to search for EHI-related statutes and regulations of the US states, US territories, and the District of Columbia in effect as of January 2014. The researchers independently catalogued provisions by the EHI use described in the law. Researchers resolved discrepancies through peer review meetings and recorded the consensus codes for each law. Results: This study identified 2364 EHI-related laws representing 49 EHI uses in 54 jurisdictions. A total of 18 EHI uses were regulated by ≥10 jurisdictions. More than 750 laws addressed 2 or more EHI uses. Jurisdictions varied by the number of EHI laws in effect, with a mean of 44 laws. Texas had the most EHI laws (n = 145). Hawaii and South Carolina had the fewest (n = 14 each). Conclusions: The EHI legal landscape is complex. The large quantity and diversity of laws complicate legal analysis, likely delay implementation of public health solutions, and might be detrimental to the development of emerging health information technology. Research is needed to understand the effect of EHI-related laws.

Domestic Legal Preparedness and Response to Ebola

Initial cases of Ebola in the U.S. raise varied legal issues as discussed at a late-breaking session at the 2014 Public Health Law conference. Session presenters share their perspectives on (1) state and local powers to quarantine and isolate persons, and (2) hospital preparedness underlying the treatment of Ebola patients.

Better health faster: The 5 essential public health law services

Successful public health campaigns like tobacco control demonstrate that effective legal interventions can be expeditiously developed, evaluated and diffused, even in the face of powerful opposition. Success for legal health interventions depends on a well-designed and nurtured legal infrastructure that assured the timely delivery of public health law services that are essential to successful policy innovation that improves health. We describe Five Essential Public Health Law Services and suggest investment in the people, methods and tools needed to move major policy initiatives from conception to widespread implementation. The model reflects a transdisciplinary approach integrating public health legal practice with law-related surveillance, evaluation and enforcement functions usually performed by public health practitioners. As an elaboration of law-related activities within the Ten Essential Public Health Services, the framework can be used to define, evaluate and strengthen public health law functions. The framework presented defines the components of a strategic investment that can turn evidence and expertise into better health, faster.

Legal Authority for Mosquito Control and Pesticide Use in the United States

Mosquito-borne diseases are a threat globally and in the United States. For instance, in the United States, the West Nile virus first appeared in 1999 and has since spread throughout the country, causing >43 937 cases as of 2015. Recently, 2 other mosquito-borne diseases, dengue virus and chikungunya virus, were locally transmitted in the continental United States for the first time. Now, with the increase in Zika virus transmission—including 4752 travel-associated cases and 220 locally acquired cases in the United States as of February 7, 2017—public health officials face the challenge of instituting effective mosquito control programs and making decisions about pesticide use. One question confronting public health officials is this: who has the legal authority for mosquito control in the United States, particularly for pesticide use and regulation? Is it the states or the federal government? The answer to this question is rooted in federalism, the scheme by which the legal authority is divided between the states and the federal government. By the earliest days of English colonial government in America, the colonies had inherited from the English King in Parliament their police powers, the natural plenary power of a sovereign state to regulate private interests for the public good, usually toward defending the health and welfare of their populations. When the Articles of Confederation were formed in 1781, the states were reluctant to give too many of these powers to a national government; thus, they retained individual authority to regulate all issues, except for a very few, including declaring war, trying pirates for crimes committed at sea, and conducting foreign policy and commerce. When the states met at the Constitutional Convention in 1787 to amend and improve the articles, they decided that a new national government was needed. The states ceded more authorities to the national government, and these authorities were expressly enumerated in article 1, section 8, of the US Constitution. These enumerated powers include, among others, the authority to raise taxes and regulate interstate commerce. The states retained all of the authority that they held prior to the US Constitution that was not expressly enumerated to the federal government. Later, in 1791, the Tenth Amendment to the Constitution recognized this reservation of authority: “The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people.” The US Supreme Court, in Jacobson v Massachusetts in 1905, reiterated that the states’ police powers include public health, holding, under a theory of self-defense, that “a community has the right to protect itself against an epidemic of disease.” As a result, states generally have the primary authority to address public health matters within their own borders, including the authority to control mosquito-borne diseases. States have a long history of intervening to control mosquito-borne diseases, beginning with outbreaks of yellow fever and malaria, and courts have supported their legal power to do so. In Paris v City of Philadelphia, the court acknowledged that “one of the most unfailing and prolific means of transmitting infectious diseases is in the development of larva, flies, mosquitoes and other disease-bearing insects” and that “it is only by rigid inspection of premises, and enforced hygienic regulation that these dangers can be controlled and minimized.”